NOVARTIS AG PsA patients with axial manifestations report higher disease burden with higher levels of pain, fatigue, morning stiffness, impairment of physical function, increased enthesitis count and higher levels of inflammatory markers9,10. They also report worse quality of life and/or work productivity11.
Cosentyx is the only fully human interleukin (IL)-17A inhibitor to demonstrate efficacy and safety in a dedicated Phase IIIb study of axial manifestations in PsA1. It is the first biologic with proven efficacy in all six key manifestations of PsA including peripheral disease, enthesitis, dactylitis, skin psoriasis and nail psoriasis2,3.
The label update reinforces Cosentyx leadership in rheumatology and immuno-dermatology, with plans to expand to 10 indications over the next 10 years.
About MAXIMISE
MAXIMISE is a 52-week, double-blind, randomized, placebo-controlled, Phase IIIb study to evaluate the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA). The trial included 485 patients with PsA and axial involvement diagnosed by the clinician, with spinal pain rated as >40/100 on a visual analog scale (VAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >4 despite a trial of at least two non-steroidal anti-inflammatory drugs (NSAIDs). This study consisted of two treatment periods; a placebo-controlled period from baseline to Week 12 (treatment period 1) followed by an active treatment period from Week 12 to Week 52 (treatment period 2). At Week 12, placebo patients were re-randomized to subcutaneous Cosentyx 300 mg or 150 mg. Patients were treated with subcutaneous Cosentyx 300 mg or 150 mg given weekly for 4 weeks and every 4 weeks starting at Week 4. The primary endpoint was the proportion of patients achieving an Assessment of
The trial met both its primary and key secondary endpoints with 62.9% and 66.3% vs 31.3% of patients treated with Cosentyx 300 mg and 150 mg vs. placebo achieving the primary endpoint, respectively. Rapid onset of improvement in the signs and symptoms of axial manifestations of PsA was seen as early as Week 4 and maintained up to Week 52. The safety profile was consistent to previous studies with no new safety signals1.
About Cosentyx (secukinumab)
Cosentyx is the first and only fully human biologic that directly inhibits interleukin (IL)-17A, a cornerstone cytokine involved in the inflammation and development of moderate-to-severe plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)13-15. Cosentyx is the only biologic with proven efficacy in all six key manifestations of PsA1-3.
Cosentyx is backed by more than 12 years of clinical experience and long-term five-year data across three indications of psoriasis, PsA and AS, as well as data from real-world evidence16-21. These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across axial spondyloarthritis, PsA and psoriatic disease, with more than 400,000 patients treated worldwide with Cosentyx since launch8.
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About Novartis
Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world.
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